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A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer

NCT00369070•Amgen

View on ClinicalTrials.gov

Summary

The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
•Measureable disease per RECIST criteria modified
•ECOG performance status of 0 or 1
•Ability to take oral medications
•Competent to give written informed consent

Exclusion Criteria

•Current or prior history of CNS metastases
•Any prior chemotherapy for advanced NSCLC
•History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
•Prior targeted therapies
•Known history of allergy or hypersensitivity to paclitaxel or carboplatin
•History of arterial or venous thrombosis within 52 weeks prior to randomization
•History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
•Peripheral neuropathy \> grade 1 per CTCAE Version 3.0
•Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
•Any kind of disorder that compromises the ability of the subject to comply with the study procedures
+4 more criteria

Key Dates

Start Date

January 31, 2007

Primary Completion Date

April 23, 2008

Completion Date

August 3, 2011

Last Updated

January 4, 2018

Enrollment

186

ACTUAL participants

Conditions

Advanced Non-squamous NSCLC

Interventions

Bevacizumab

BIOLOGICAL

AMG 706

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG